BRIGHT GOLD XH by IVOCLAR VIVADENT, INC.

I am sorry, but based on the provided text, I cannot provide a description of the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a dental alloy named "Bright Gold xh" (and later corrected to "Brite Gold XH").

The letter states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device has been found to be as safe and effective as a device already on the market, but it does not include details about specific performance acceptance criteria or a study demonstrating that the device meets those criteria.

The document primarily focuses on:

The device name and regulation details.
The FDA's finding of substantial equivalence.
Regulatory requirements and responsibilities for the manufacturer.
The intended indications for use (onlays, ¾ crowns, crowns, short span bridges, PFM crowns).

It does not contain the specific information requested in your prompt regarding:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance of a test set.
Number or qualifications of experts for ground truth establishment.
Adjudication method for a test set.
MRMC comparative effectiveness study results.
Standalone algorithm performance.
Type of ground truth used.
Sample size for a training set.
How ground truth for the training set was established.

These kinds of details would typically be found in the premarket notification submission itself (which is not provided here) or in a separate study report, not in the FDA's clearance letter.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white circular logo. The logo features the seal of the U.S. Department of Health and Human Services. The seal includes an abstract image of an eagle with three wavy lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Public Health Service

7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Anderjeet Gulati Quality Assurance Manager Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K041433

Trade/Device Name: Bright Gold xh Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJS Dated: May 18, 2004 Received: May 28, 2004

Dear Mr. Gulati:

This letter corrects our substantially equivalent letter of August 19, 2004 regarding the trade name.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent [{for the indications for use stated in the enclosure)] to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Page-2 Mr. Gulati

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin. Ph.D Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

{2}------------------------------------------------

510(k) Number (if known):	K041433
---------------------------	---------

Device Name:

Bright Gold ..............................................................................................................................................................................

Indications For Use:

Brite Gold XH alloy intended to be used for onlays, % crowns, crowns and short span bridges PFM crowns

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Swen Purry

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K041432

Prescription Use_メ (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.3060 Noble metal alloy.

(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.